Shaafi Naturcure LLP filed Indian Patent Application No. 201911048481 for “A Herbal Powder Composition for the Treatment of Asthma.” The claimed composition contained six herbs: Tephrosia purpurea, Cuscuta reflexa, Morinda citrifolia, Terminalia arjuna, Piper longum, and Piper nigrum.<\/p>\n
The applicant claimed specific weight ranges for these herbs and also claimed a process for preparing the composition. The process involved shade drying the herbs, crushing or grinding them separately, and mixing the powders in the claimed ratios.<\/p>\n
The Assistant Controller refused the patent application on the grounds that the claimed invention did not meet the requirements of Sections 2(1)(j) and 2(1)(ja), was not patentable under Section 3(p), and did not satisfy Sections 10(4)(a) and 10(4)(b) of the Patents Act.<\/p>\n
The applicant filed an appeal before the Delhi High Court.<\/p>\n
The applicant argued as follows:<\/p>\n
The respondent argued as follows:<\/p>\n
The Court first rejected the applicant’s argument based on the Biological Diversity Act and the approval granted by the National Biodiversity Authority. According to the Court, the Biological Diversity Act deals with conservation of biological diversity, sustainable use of biological resources, and benefit sharing. It does not confer power on the National Biodiversity Authority to decide whether a claimed invention is patentable. Patentability has to be decided under the Patents Act.<\/p>\n
The Court then considered the claimed invention and the prior art. The judgment recorded that the claimed composition contained six herbs and that the cited prior art disclosed uses of those herbs, individually or in related formulations, for asthma, bronchitis, cough, or similar respiratory conditions.<\/p>\n
The applicant’s case rested largely on synergy. The applicant said that the six herbs, in specific ratios, produced an effect that could not be obtained from individual herbs or other combinations. The Court, however, found that the complete specification did not adequately disclose this technical effect.<\/p>\n
The Court observed that the inventor’s affidavit mentioned five types of asthma and claimed that the composition worked for all five. But the complete specification did not disclose those five types of asthma. The Court also noted that the affidavit referred to negative effects of altered ratios, but the specification did not disclose those negative effects.<\/p>\n
According to the Court, post filing evidence may be considered only when it confirms a technical effect already present in the complete specification. It cannot be used to establish such technical effect for the first time. On that basis, the Court held that the affidavit data could not be relied upon to cure gaps in the specification.<\/p>\n
The Court also found a contradiction in the applicant’s own specification. The claim was based on a six ingredient composition, but one example in the complete specification showed that a four ingredient composition also gave significant relief from asthma. As per the Court, this weakened the applicant’s case that all six herbs were necessary for the claimed technical effect.<\/p>\n
The Court then applied the Traditional Knowledge Guidelines. The judgment referred to Guiding Principle 2, under which combining plants already known for treating the same disease is considered obvious when all plants were previously known for that disease. It also referred to Guiding Principle 4, under which discovering optimum or workable ranges of traditionally known ingredients by routine experimentation is not inventive.<\/p>\n
In the Court’s view, the applicant had not established synergy. Since the six ingredients were already known for treating asthma or related respiratory ailments, and since the complete specification did not support the alleged synergistic effect, the claimed composition lacked inventive step and was also hit by Section 3(p).<\/p>\n
The Court also upheld the objections under Sections 10(4)(a) and 10(4)(b). Since the specification did not fully disclose the claimed technical effect, and since the applicant could not rely on later affidavit data to fill the gap, the Court held that the complete specification did not fully and particularly describe the invention and did not disclose the best method of performing it.<\/p>\n
The findings of the Court are as follows:<\/p>\n
“There is no provision in either the BDA or the Rules which confer any power or authority or even jurisdiction to the NBA to venture into or conduct any inquiry in any manner whatsoever with respect to the patentability or otherwise of any claimed invention. Thus, the mere grant of approval by the NBA has no rationale or remote nexus with the patentability of a claimed invention, which is the exclusive mandate of the Patents Act, 1970.”<\/p><\/blockquote>\n
Para 40:<\/h3>\n
“Indeed the appellant in its CS had not disclosed any information regarding 5 different variants of asthma. Besides, even in the affidavit of the inventor, no evidence or documentary proof of such different variants of asthma were submitted. Thus, there being no tangible material or evidence of existence of different types of asthma, the claim now brought forth in the affidavit rightly could not be considered by the learned Controller.”<\/p><\/blockquote>\n
Para 47:<\/h3>\n
“It is important to note that if an applicant files additional data before the Patent Office, the addition of any descriptive material has to be at least implicitly disclosed in the specification.”<\/p><\/blockquote>\n
Para 50:<\/h3>\n
“In view of the above ratio and having regard to the fact that the CS is silent regarding the negative effects of the composition in case the ratio of ingredients in the composition is changed, the data provided under paragraph 8 of Annexure 1 of the affidavit submitted by the appellant cannot be permitted to be taken into consideration and has rightly been rejected by the respondent.”<\/p><\/blockquote>\n
Para 53:<\/h3>\n
“The composition (f.) under Example 6, has 4 ingredients only and it still results in significant relief from asthma. In view of the above discussed reasoning of non acceptance of data provided under the affidavit and issues discussed regarding the examples of the CS, we hold that the present invention lacks the inventive step under Section 2(1)(ja) of the Act.”<\/p><\/blockquote>\n
Para 56:<\/h3>\n
“In the absence of the synergy of the compound under the claimed composition, the present invention lacks an inventive step as per the definition of Section 2(1)(ja) of the Act.”<\/p><\/blockquote>\n
Para 60:<\/h3>\n
“The TK guidelines under principle 2 state that the combination of plants with already known therapeutic effects with further plants with the same known therapeutic agents is considered to be an obvious combination if all plants are previously known for treating the same disease. Similarly, the guiding principle 4 states that discovering the optimum\/workable ranges of traditionally known ingredients by routine experimentation is not inventive.”<\/p><\/blockquote>\n
Para 62:<\/h3>\n
“Thus, applying the scheme provided in the aforesaid Guiding Principle no.2 and 4 to the facts of the claimed invention and considering the absence of synergy as discussed earlier, it appears that the combination of the ingredients present therein are already known for their treatment of asthma and adding further ingredients with same known effects would fall foul of Section 3(p) of the Act. Therefore, the subject application is not patentable under Section 3(p) of the Act.”<\/p><\/blockquote>\n
Para 64:<\/h3>\n
“In view of the issues regarding the CS discussed above, the rejection of the data submitted through the affidavit and considering the abovementioned judgement in AstraZeneca AB (supra), the CS is not fully and particularly disclosing the claimed invention as required under Section10(4)(a) of the Act. Additionally, the present invention also fails to disclose the best method of performing the invention as required under Section 10(4)(b) of the Act.”<\/p><\/blockquote>\n
Case Citation<\/h2>\n